Medical materials.
Documented chain.
Compliant by design.
FDA and USP Class VI designations mean specific material certifications and processing requirements for medical and pharmaceutical contact. Designing for compliance from the start avoids costly material changes later.
Key principles.
USP VI grade
PEEK-OPTIMA, USP VI silicone, FDA-compliant 316L. Specify by USP VI compliance, not just material.
From mill
Material certificate from mill heat through finished part. Required for medical traceability.
Pure substrate
Avoid coatings, fillers, additives unless specifically USP VI rated. Each adds compliance burden.
Cleanability
Smooth surfaces (Ra 0.8 µm or better) for cleaning. Crevices harbor bacteria.
Drainable design
Drainable, cleanable design. Sanitary 3-A standard for some applications.
Material-process
Specify sterilization method (gamma, EtO, autoclave). Material compatibility matters.
FAQ
USP Class VI testing details?
Systemic toxicity, intracutaneous reaction, intramuscular implantation testing per USP. Materials passing become Class VI rated.
FDA vs USP VI?
FDA 21 CFR 177 covers food contact materials. USP VI covers medical device implantation testing. Different applications.
PEEK-OPTIMA importance?
Invibio PEEK-OPTIMA is USP Class VI certified for implants. Standard for spinal cages, orthopedic. Premium over industrial PEEK.
Documentation cost?
Medical-grade documentation adds 10-20% to part cost. Includes mill certs, processing records, inspection per AS9102.
Sterilization affects material?
Yes. Gamma may degrade some plastics. Repeated autoclave fatigues materials. Specify sterilization compatibility for chosen material.
Design partner needed?
Medical device development requires regulatory expertise. We manufacture per spec; customer responsible for FDA submission, 510(k), etc.
Get an instant quote
Send your CAD — we reply with detailed pricing, lead time, and DFM feedback within 4 working hours.
Start quoteTalk to an engineer
WhatsApp our team directly. Most messages answered within 12 minutes during work hours.
Open WhatsAppExplore all services
CNC, 3D printing, injection molding, sheet metal, casting, finishing — one quality system, one partner.
See all services